Company to host webcast and conference call at
For fiscal 2014, the company’s annual net sales are expected to be in
the range of
Also for fiscal 2014,
“We are pleased with the progress
Mallinckrodt’s low-risk, high-productivity approach to R&D will remain a focus and source of future growth for the company. The current development pipeline contains various products and product candidates resulting from the reformulation of existing molecules for the treatment of pain and for treatments in complementary therapeutic areas. The following product candidates in the development pipeline represent the most significant near-term commercial opportunities in the company’s Brands business.
MNK-795 is an investigational, extended-release oral formulation
of oxycodone and acetaminophen that has been studied for the management
of moderate to severe acute pain where the use of an opioid analgesic is
appropriate. The tablet was designed using technology with immediate-
and extended-release components and potentially tamper-resistant
MNK-155 is a reformulation of hydrocodone and acetaminophen. The formulation includes certain tamper-resistant characteristics designed to deter particular types of abuse. MNK-155 entered Phase III clinical trials in the first half of fiscal 2013. Completion of the clinical program and an NDA filing for MNK-155 is expected by the end of fiscal 2014.
MNK-395 is a 2% formulation of diclofenac topical solution that
has been studied in twice-daily administration for the potential
indication of the treatment of pain associated with osteoarthritis of
the knee. The
2014 Mallinckrodt Fiscal Year Guidance (excluding foreign currency impact)
|Adjusted diluted EPS||$2.45 to $2.65|
|Total company net sales||$2.15 billion to $2.25 billion|
|Specialty Pharmaceuticals net sales||$1.22 billion to $1.27 billion|
|Global Medical Imaging net sales||$885 million to $930 million|
|Methylphenidate ER net sales||At least $120 million|
|Non-GAAP effective tax rate||26% to 29%|
|Capital expenditures||$140 million to $160 million|
Webcast and Conference Call
The company will hold a conference call for investors today,
(2)NON-GAAP FINANCIAL MEASURES
This press release contains financial measures, including adjusted
diluted EPS and operational growth, which are considered “non-GAAP”
financial measures under applicable
Adjusted diluted EPS represents diluted EPS prepared in accordance with
accounting principles generally accepted in
Operational growth measures the change in net sales between current- and prior-year periods using a constant currency, the exchange rate in effect during the applicable prior-year period. This measure is one of the performance metrics that determines management incentive compensation.
We have provided these non-GAAP financial measures because they are used by management, along with financial measures in accordance with GAAP, to evaluate our operating performance. In addition, we believe that they will be used by certain investors to measure our operating results. Management believes that presenting these non-GAAP measures provides useful information about our performance across reporting periods on a consistent basis by excluding items that we do not believe are indicative of our core operating performance.
These non-GAAP measures should be considered supplemental to and not a substitute for financial information prepared in accordance with GAAP. The company’s definition of these non-GAAP measures may differ from similarly titled measures used by others.
Because non-GAAP financial measures exclude the effect of items that will increase or decrease the company’s reported results of operations, management strongly encourages investors to review the company’s consolidated financial statements and publicly filed reports in their entirety.
Any statements contained in this communication that do not describe
historical facts may constitute forward-looking statements as that term
is defined in the Private Securities Litigation Reform Act of 1995. Such
forward-looking statements include, but are not limited to, statements
about future financial condition and operating results, economic,
business, competitive and/or regulatory factors affecting our business.
Any forward-looking statements contained herein are based on our
management's current beliefs and expectations, but are subject to a
number of risks, uncertainties and changes in circumstances, which may
cause actual results or company actions to differ materially from what
is expressed or implied by these statements. The factors that could
cause actual future results to differ materially from current
expectations include, but are not limited to, our ability to receive
procurement and production quotas granted by the
1 Total company net sales includes approximately
John Moten, 314-654-6650
Vice President, Investor Relations
Lynn Phillips, 314-654-3263
Manager, Media Relations
Meredith Fischer, 314-654-6595
Senior Vice President, Communications